Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Not Applicable

Completed

• Conditions: Back Pain; Supplementation
• Interventions: Other: Control product consumption; Dietary Supplement: Experimental product

• Registration Number: NCT05597189
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief Summary

Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.

Detailed Description

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day.

The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-26
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Primary Completion: 2023-06-26
• Study Completion: 2023-07-31
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• Men and women between 20 and 65 years of age.
• The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
• The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
• The pain must be episodic.
• BMI 18.5 - 29.9 kg/m2.
• Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.

Exclusion Criteria

• Severe or terminal illnesses.
• Subjects with pain associated with trauma.
• Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
• Subjects with known allergy to any of the components of the investigational product. the investigational product.
• Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
• Pregnant or lactating women.
• Inability to understand the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control product consumption	Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.
Botanical extracts low dose	Experimental product	Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.
Botanical extracts high dose	Experimental product	Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast.

Primary Outcome Measures

Name	Time	Method
Change in Pain from baseline at 12 weeks	The evolution of pain after consumption during 12 weeks will be measured.	Visual analog scale from 0 to 10. The higher the value, the more pain.

Secondary Outcome Measures

Name	Time	Method
Evaluation of back pain: Promis-29 test	Day 1, at 4, 8 and 12 weeks later	Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain.
Sleep efficiency	The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.	Measured by accelerometry, with Actigraph wGT3X-BT
Anxiety questionnaire	Day 1, at 4, 8 and 12 weeks later	Test STAI, to measure the level of anxiety of the subjects
Perceived stress	Day 1, at 4, 8 and 12 weeks later	Remor, 2001. Test to measure the level of stress of the subjects
Sleep quality	It will be measured twice, once at baseline or at the end of the study after 12 weeks of use	Measured by Pittsburgh test
Physical activity	The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.	It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT
Wellbeing / wellness	Day 1, at 4, 8 and 12 weeks later	WHOQOL BREF test
Evaluation of back pain: Cornell	Day 1, at 4, 8 and 12 weeks later	The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) assesses musculoskeletal symptomatology in workers who perform sedentary and standing work. sedentary work and standing work.
Level of functionality: Roland Morris test	Day 1, at 4, 8 and 12 weeks later	The Roland-Morris questionnaire is used to reliably determine the degree of physical degree of physical disability derived from non-specific low back pain.
Quality of life questionnaire	Day 1, at 4, 8 and 12 weeks later	SF-36 test health questionnaire
Body composition	The test will be measured at baseline and after 12 weeks of consumption.	It is a control variable. Measured by bioimpedance
C Reactive Protein (PCR)	It will be measured twice, once at baseline or at the end of the study after 12 weeks.	It is a blood test that measures inflammation levels.
Change in concomitant analgesic medication	The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis	The change in the need for the use of analgesic medications will be evaluated
Depression	Day 1, at 4, 8 and 12 weeks later	Beck depression. Test to measure the level of depression of the subjects
Interleukin 6 (IL-6)	It will be measured twice, once at baseline or at the end of the study after 12 weeks.	It is a blood test that measures inflammation levels.
Liver safety variables	It will be measured twice, once at baseline or at the end of the study after 12 weeks.	It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain